Protocol summary
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Study aim
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Determining the effect of educational intervention based on the Ottawa nutritional guide on nausea and vomiting in pregnant women
Specific goals.
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Design
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Clinical trial with a control group, a blinded, randomized, on 60 patients. Random Allocation Software was used for randomization.
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Settings and conduct
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Random placement of pregnant women referring to women's clinics and specialized clinics of selected gynecologists in two groups. Blinding will only be done for the data analyst.
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Participants/Inclusion and exclusion criteria
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Entry: The gestational age should be 4-16 weeks (4 full weeks to 15 weeks and 7 days)، Singleton pregnancy، Mother's age should be 15-45 years، Be literate in reading and writing، Not suffering from a known physical or mental illness، Do not use drugs to reduce nausea and vomiting except vitamin B6، Score 3-16 in response to the Rhodes questionnaire، Body mass index is equal to or less than 30، Do not have hearing, speech or mental retardation، Do not smoke, use drugs or alcohol.
Exit: Obstetrical problems may occur during the study، Vomiting that has a cause other than pregnancy، Being hospitalized due to severe nausea and vomiting of pregnancy.
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Intervention groups
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The educational program will be presented during two 60-minute sessions in groups of two to five people of the Ottawa nutrition guide training with the methods of lectures, questions and answers, group discussions, lectures and slide shows. The educational content will include: the first session, general Ottawa guidelines for nausea and vomiting and the second session, other points will include lifestyle changes, complementary medicine, acupressure (practical finger acupressure training). During the study, the control group only received routine pregnancy training and did not receive any training from the researcher.
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Main outcome variables
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Average total score of nausea, vomiting and belching in pregnant women
General information
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Reason for update
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The expected time for sampling was incorrectly entered.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180218038783N5
Registration date:
2023-09-03, 1402/06/12
Registration timing:
prospective
Last update:
2023-12-28, 1402/10/07
Update count:
1
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Registration date
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2023-09-03, 1402/06/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-01, 1402/08/10
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Expected recruitment end date
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2025-03-19, 1403/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of Educational Intervention based on the Ottawa Nutritional guide on Nausea and Vomiting in Pregnant women
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Public title
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Investigating the ٍEffect of Educational Intervention based on the Ottawa Nutritional guide on Nausea and Vomiting in Pregnant women
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
The gestational age should be 4-16 weeks (4 full weeks to 15 weeks and 7 days).
Singleton pregnancy.
Mother's age should be 15-45 years.
Be literate in reading and writing.
Not suffering from a known physical or mental illness.
Do not use drugs to reduce nausea and vomiting except vitamin B6.
Score 3-16 in response to the Rhodes questionnaire.
Body mass index is equal to or less than 30.
Do not have hearing, speech or mental retardation.
Do not smoke, use drugs or alcohol.
Exclusion criteria:
Obstetrical problems may occur during the study.
Vomiting that has a cause other than pregnancy.
Being hospitalized due to severe nausea and vomiting of pregnancy.
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Age
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From 15 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Pregnant women will be included in the study if they are eligible based on the entry criteria and after obtaining written informed consent. Due to the fact that the subjects of the study do not enter the study at the same time, and the researchers cannot predict in advance which group each person who enters the study will belong to. To
assigning the target group to one of the two study groups; The intervention group and the control group (two groups A and B) will use the Block Randomization method with ten blocks.
Then the participants will be assigned to one of two groups 1 with a ratio of 1:1 according to the block randomization protocol (produced by Random Allocation Software), so that the researcher cannot predict which group the next person will be in. intervention will be placed.
Randomization list based on software output:
Allocation concealment
In order to hide the random assignment, the codes created by the software will be placed in the envelope so that it is not clear which group the next person will be assigned to.
Concealment of random allocation refers to the method used to perform a random sequence on the participants in the study, so that the assigned group is not known before the allocation of the individual. Without hiding the random sequence, there is a possibility of revealing the random sequence, which ultimately weakens the randomization process. Therefore, it is necessary for people who have the criteria to enter the research, a decision to accept or reject participation in the study should be made first and the informed consent form should be completed and then the participants will be assigned to each of the groups. Different methods can be used to hide random allocation. In this study, the method of opaque sealed envelopes with random sequence will be used.
Based on the sample size of this research, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, considering that after randomization, the pregnant women themselves and the interventionist cannot be blinded (because the type of intervention is known). Completing questionnaires is also self-reported. Therefore, blinding cannot be done in the first stage. Blinding will only be done for the data analyst.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-08-28, 1402/06/06
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Ethics committee reference number
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IR.MUBABOL.HRI.REC.1402.079
Health conditions studied
1
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Description of health condition studied
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Nausea and vomiting of pregnancy
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ICD-10 code
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R11
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ICD-10 code description
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Nausea and vomiting
Primary outcomes
1
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Description
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Average total score of nausea, vomiting and belching in pregnant women
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Timepoint
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During the first two weeks from the beginning of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete, and the intervention group will also be given a checklist for carrying out the Ottawa recommendations. Then, for another two weeks, the intervention and control groups will be given the Rhodes questionnaire and the intervention group will be given the Ottawa educational guide implementation checklist to complete. Pregnant women should complete the Rhodes questionnaire based on their conditions three days before handing it over to the researcher.
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Method of measurement
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Rhodes Nausea and Vomiting Index
Secondary outcomes
1
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Description
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Average sexual satisfaction score
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Timepoint
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Before the beginning and after the fourth week of the intervention
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Method of measurement
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Hudson sexual satisfaction questionnaire
Intervention groups
1
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Description
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Intervention group: After people are placed in two intervention and control groups, two days a week will be determined for pregnant women in the intervention group, one day before the training session, pregnant women will be reminded through a phone call. Educational program during two 60-minute sessions in groups of two to five people, Ottawa nutrition guide training (general guidelines; nutritional recommendations; other recommendations on lifestyle and acupressure) with lecture methods, question and answer and group discussion, lecture with slide show will provide. The educational content will include: the first session, general Ottawa guidelines for nausea and vomiting and the second session, other points will include lifestyle changes, complementary medicine, acupressure (practical finger acupressure training). After the end of the second session, the content will be provided to the intervention group in the form of a booklet for studying at home. During the first two weeks from the start of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete, and the intervention group will also be given the Ottawa recommendations checklist to complete every night before going to bed. During these two weeks, telephone calls will be made to the intervention group twice a week with an interval of three days to answer their possible questions and to emphasize on doing the things taught. Then, for another two weeks, the intervention and control groups will be given the Rhodes questionnaire and the intervention group will be given the Ottawa educational guide implementation checklist to complete. Pregnant women should complete the Rhodes questionnaire based on their conditions three days before handing it over to the researcher. If someone from the intervention group does not complete the checklist, they will be excluded from the study. After four weeks, both control and intervention groups will complete Hudson's sexual satisfaction questionnaire. Routine pregnancy care will be provided in both groups, and if a member of the intervention and control groups experiences severe nausea and vomiting during pregnancy or is exposed to dehydration and possible complications, they will be referred to medical centers for necessary measures.
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Category
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Other
2
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Description
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Control group: During the first two weeks from the beginning of the study, all the participants of the intervention and control groups will be given the Rhodes questionnaire to complete. Then, for another two weeks, the Rhodes questionnaire will be completed again for the intervention and control groups. After four weeks, both control and intervention groups will complete Hudson's sexual satisfaction questionnaire. During the study period, routine pregnancy care will be performed in the control group.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available